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临床试验/NCT02334410
NCT02334410Unknown不适用

Early Intervention to Reduce Bone Loss After Spinal Cord Injury

University of Strathclyde2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年2月最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
2
主要终点
Rate of change of bone mineral density (BMD) based on peripheral Quantitative Computed Tomography (pQCT) bone scans

研究概览

简要总结

After a complete spinal cord injury (SCI), the patient becomes wheelchair-dependent, and the associated lack of weight-bearing and inactivity of paralysed muscles can lead to extensive bone loss in the long bones of the legs. It has been documented that the most rapid phase of bone loss is during the first year, but bone loss can continue for a number of years post-injury, leading to an increased risk of fracture in chronic SCI. Through a previous longitudinal study, in which we described rates of bone loss in the first year of SCI using peripheral Quantitative Computed Tomography (pQCT), we showed that there is a subset of patients who suffer from extremely rapid bone loss, losing up to 50% of their bone mineral density (BMD) in the first 12 months post-SCI. As a result of this work, we now know that, by performing repeat bone scans within months of injury, we are able to detect and "red-flag" those patients at highest risk of rapidly weakening bones. We propose that, once these patients have been identified, there is an opportunity to intervene with bone-stimulating interventions within months of injury, before BMD reaches dangerously low values. In this new phase of the research, therefore, we are introducing an intervention phase to the longitudinal pQCT study. For this, we aim to trial a physical intervention, Whole Body Vibration (WBV), that could potentially reduce rates of further bone loss in fast bone losers. Vibration would achieve this by acting as a mechanical stimulus for bone cells, to encourage bone formation. If shown to be successful as an early bone-stimulating intervention, it may prove to be a tool for reducing future fracture risk in patients with SCI.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Motor-complete spinal cord injury (SCI)
  • SCI at neurological levels C4 and below
  • Within six weeks of SCI

排除标准

  • Recent bilateral fractures in tibia and/or femur
  • Previously diagnosed osteoporosis
  • Pregnancy

结局指标

主要结局

Rate of change of bone mineral density (BMD) based on peripheral Quantitative Computed Tomography (pQCT) bone scans

时间窗: 12 months

Can WBV intervention reduce the rate of bone loss in patients with early spinal cord injury?

Rate of change of calcium and bone profiles based on blood samples

时间窗: 12 months

Biochemical markers of bone formation, bone resorption, hormone and mineral levels.

次要结局

  • Correlation between imaging and biochemical markers of bone health(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sylvie Coupaud

Dr

University of Strathclyde

研究点 (2)

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